Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT00196118
Eligibility Criteria:
Inclusion Criteria:
* Patient must be considered at high risk for PE, but placement of a permanent IVC filter is not likely to be required.
* Patient must have a patent internal jugular vein.
* Patient has given informed consent.
Exclusion Criteria:
* Patient is less than 18 years.
* Patient has a pre-existing filter
* Patient had indications for a permanent filter at the time of the initial evaluation.
* Patient has uncontrollable coagulopathy.
* Patient has a short life expectancy \< 6 months.
* Patient has metastatic malignancy.
* Patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
* Patient has a contrast allergy that cannot be adequately pre-medicated.
* Patient is at risk of septic embolism.
* Patient has sepsis.
* Patient has a hypersensitivity to any of the components of the GT filter, specifically cobalt, nickel, and chromium.
* Patient has impaired renal function (creatinine \> 2.0).
* Patient is pregnant or planning to become pregnant within the next 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00196118
Study Brief:
Protocol Section:
NCT00196118